If a quality defect is found in a product with Swiss approval (main authorisation or export approval), this must be reported to Swissmedic using the appropriate form and within the given deadlines. The reporting obligation exists regardless of whether the product is exported or not, and also whether it is distributed in Switzerland or not. Therefore, a quality defect must always be reported to Swissmedic.
Dr. Katharina Oehler
Scientific and Managing Director
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